Dr. Stults is Principal at C & M Technical Consulting, LLC, working with various local and global companies to advance the development of parenteral and inhalation products. Her primary area of focus is on device and packaging materials analysis and characterization for purposes of selection, qualification and control. She holds a Ph.D. in Analytical Chemistry from Michigan State University and a Masters in Management from Aquinas College. Prior positions include: Senior Fellow at Novartis Pharmaceuticals Corporation, Assistant Research Professor at San Francisco State University and Quality Associate at a Johnson & Johnson owned company. She was co-editor of the Leachables and Extractables Handbook (Wiley 2012) and has been a member of the Board of Directors for two consortia: Extractables and Leachables Safety Information Exchange (ELSIE) and International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS). She has been actively involved in the ELSIE Pilot Protocol Study and database development. She previously led IPAC-RS working groups to develop Materials Baseline Requirements for OINDP, a Leachables and Extractables Development Paradigm and a Chemical Risk Evaluation tool and has continued involvement as an IPAC-RS Science Advisor participating in global outreach and materials related initiatives. Dr. Stults is currently a USP Packaging and Distribution Expert Committee member contributing to development and revision of materials-related chapters.
Hall Analytical Laboratories
Nick is a Principal Scientist at Hall Analytical Laboratories responsible for providing technical support to new and existing pharma, med device and ENDs customers in the field of extractables and leachables. Nick’s area of expertise includes E&L study design, defining E&L strategies, performing leachable risk assessments and authoring E&L regulatory sections.
Prior to joining Hall, Nick spent over 10 years at GSK in the field of extractables and leachables. During this time, he worked on a range of therapeutic areas including inhalation, topical and parenteral. Where he had responsibility for the E&L assessment of devices, closure systems and manufacturing processes to ensure patient safety, product quality and regulatory approval.
Risk Science Consortium, LLC & US FDA (Retired)
Ron Brown is a toxicologist with 35 years of experience in regulatory toxicology and risk assessment. He recently retired from the US FDA after 25 years of service and currently directs a small company, Risk Science Consortium, LLC, that provides consultation and training in toxicological risk assessment and computational toxicology. At the FDA, Ron was the senior toxicologist responsible for developing and reviewing toxicological risk assessments of extractable and leachable (E&L) compounds from medical devices. Prior to his position at the US FDA, Ron served as a Senior Associate at the ILSI Risk Science Institute. He is founding member and former President of the Medical Device and Combination Products Specialty Section of the Society of Toxicology and former President of the Dose-Response Specialty Section of the Society for Risk Analysis.
Charles E Ducker
Eurofins Medical Device Testing
Bio coming soon!
Global Risk Assessment Services Toxicologist, Drug Safety Research & Developmentat
Trish joined Pfizer in February 2020 as a Global Risk Assessment Services Toxicologist in Drug Safety R&D. Trish has a background in Genetic Toxicology and over the last 12 years has built expertise in mutagenic impurity, extractable and leachable, and contamination risk assessments. In recent years, Trish participated in ICH M7 working group to develop Appendix 3 and co-authored hydrogen peroxide monograph. In addition, she authored the vinyl acetate monograph in the subsequent publication Bercu et al., (2018). Trish is also the co-chair of the Extractables and Leachables Safety Information Exchange (ELSIE) PDE and Sensitisation Sub-teams and is an active member of the EFPIA working group to support ICHQ3E.
Valériane Levelut, PHARMD, ERT, DABT
Valériane is a Pharmacist, specializing in regulatory toxicology and with experience in cosmetics, food, chemicals, biocidal products and medical devices. Prior to joining NAMSA in 2020, Valériane worked for different Contract Research Organizations (CROs) where she was responsible for the safety assessment of various types of consumer products. She also has strong experience in worldwide regulations (including Europe, the U.S. and Asia), helping manufacturers obtain regulatory approval of their products in different regions.
Valériane holds a Master’s Degree (MSc) in Toxicology and obtained the Eurotox (ERT) certification in 2019; she has also been a Diplomate of the American Board of Toxicology (DABT) since 2021.
Daniel Norwood, Ph.D.
Feinberg Daniel Norwood & Associates Pharma Consulting
Dr. Norwood is an internationally recognized expert in the field of leachables and extractables assessment in pharmaceutical development and manufacturing. He served as chair of the widely-quoted Product Quality Research Institute (PQRI) Working Group on leachables and extractables in inhalation drug products. He is also a member of the PQRI Working Group on leachables and extractables in parenteral and ophthalmic drug products (PODP), and has served on various technical teams of the International Pharmaceutical Aerosol Consortium on Regulations and Science (IPAC-RS). Since 2010, he has served as a member of the USP Expert Committee on Packaging, Storage and Distribution where he chairs the subcommittee on extractables and leachables. Dr. Norwood has received several industry awards, including the CEO’s Award from Glaxo (1994), the President’s Award from Boehringer Ingelheim (2007), the Excellence in Research Award from PQRI (2009), and the Award for an Innovative Response to Public Health Challenges from USP (2013). Dr. Norwood completed his bachelor’s degree in Biochemistry at Virginia Tech and his doctorate degree in Environmental Chemistry at the University of North Carolina at Chapel Hill, School of Public Health.
Dr. Matthew Jorgensen
Senior Extractables and Leachables Expertat
I am a seasoned scientist with a diverse background in chemistry and material sciences. Currently I focus my efforts on using chemistry in the evaluation of medical device biocompatibility. My academic work has focused on synthesis and characterization of biomimetic materials, fabrication of microscale devices, and photonics. I have a professional interest in both technical and popular science writing, which has produced over 30 peer reviewed scientific articles and hundreds of blog articles.
At Nelson Labs I draw on my chemistry and materials experience as well as my research acumen to create solutions for sponsors with interesting and challenging problems facing the assessment of their devices.
Dr. Martyn Chilton
Dr Martyn Chilton is a Principal Scientist at Lhasa Limited, where he leads the research efforts around creating, improving, and applying in silico models to predict skin sensitisation and related toxicity endpoints. His background is in organic chemistry, having received a master’s degree and PhD from the University of Sheffield. Since joining Lhasa Limited in 2015 he has been interested in the role that computational approaches can play in the toxicological safety and risk assessment of chemicals, and he has been fortunate to be involved in several interesting projects in this field, collaborating with scientists across the pharmaceutical, cosmetic, and personal care industries. Recently he was a member of the OECD working group which helped create the guidance document on defined approaches for skin sensitisation, the first such international guidance to include in silico sensitisation models alongside in chemico and in vitro experiments.
With over 25 years' experience, Ms. Schaible is responsible for oversight and direction of WuXi AppTec's Analytical Chemistry department in St Paul, Minnesota. The analytical staff she manages is responsible for providing custom chemistry testing services including extractables/leachables, materials characterization and target analysis testing, method development, method validation as well as standardized testing including compendial testing. Ms. Schaible received her Bachelors of Science in Chemistry from Winona State University, and has experience working in the pharmaceutical, medical device, environmental and R&D industries, including over 15 years of analytical experience in GLP, GMP, FDA and ISO regulated laboratories. Ms. Schaible provides technical guidance and testing program design, and is an international and U.S. delegate for TC 194, the technical committee for ISO 10993.
Benton Cartledge, Ph.D.
Dr. Cartledge is an associate research scientist with the extractables and leachables group at PPD® Laboratories in Middleton, Wisconsin. In 4 years at PPD, he has performed extractables and leachables studies including routine stability testing, controlled extraction studies, method development and validation, and medical device studies. He has successfully executed many programs leading to drug product approval by the FDA.
Kevin Rowland, M.S. received his bachelor’s degree in ceramic engineering in 2001 followed by a master’s degree in 2003 in materials science and engineering both from Alfred University. He then received a master’s degree in chemistry from Brown University under Dr. Brian Moulton in 2008 with research focusing on molecular self-assembly. Kevin has been at Jordi Labs for 11 years and has served as team leader for the GCMS and LCMS groups. His work has focused on interpretation of high-resolution accurate mass MS data for identification of non-target, unknown compounds. He is currently serving as Laboratory Manager.
Allan W. Ader, Ph.D., DABT
Co-Founder and Principal Toxicologistat
SafeBridge Consultants, Inc.
Dr. Allan Ader is co-founder and Principal Toxicologist for SafeBridge Consultants, Inc., the premier resource for high level risk assessment, safety, health and environmental support to the biotechnology and pharmaceutical industry, located in Mountain View, CA. Dr. Ader has extensive experience in:
Developing Occupational Exposure Limits and assessing compounds for toxicity and potency for compound categorization / banding and recommending handling practices and controls based on the toxicity/potency characteristics;
Assisting companies in testing of chemicals for their toxic effects and interpreting data from these tests,
Performing health-based risk assessments including evaluating toxicological and exposure information to determine potential health effects of chemicals, and
Responding to crises caused by occupational health illnesses from chemicals by assessing and evaluating risks and communicating them to employees and management.
Dr. Ader has over 25 years of experience in the pharmaceutical and chemical industry including working for Syntex, Inc. in Palo Alto, CA and Olin Corporation, New Haven, CT. He received a Ph.D. in Industrial Health (Toxicology) from the University of Michigan and an M.S. in Industrial Hygiene from Temple University. He is a Diplomate of the American Board of Toxicology.
Robert E. Malick
Principal Research Scientist II, Combination Products, Operations Science & Technologyat
Robert Malick is a Principal Research Scientist II in Operations Science & Technology Combination Products with AbbVie. He started his 30th year at AbbVie/Abbott having joined after receiving his Ph.D. in Analytical Chemistry from the University of Cincinnati. Robert has been active in extractable & leachables since 2006 for dosing devices and container closure systems ranging from metered dose inhalers to implantable devices. He has spoken at several conferences, chaired industry working sessions and has several publications in the E&L field. Robert is active with industry consortia including ELSIE (Extractables and Leachables Safety Information Exchange), currently serving as Co-Chair of the Materials Safety Working Group and representing AbbVie on the ELSIE Board of Directors.
Erica Dahl, Ph.D., DABT
SafeBridge Regulatory & Life Sciences Group
Board certified toxicologist.
Expertise in occupational toxicology, including hazard assessment of potent pharmaceuticals, product quality, and genetic toxicology.
Instructor for the SafeBridge Potent Compound Safety Boot Camp
Former study director for non-animal safety studies of pharmaceuticals, consumer products and cosmetics in a GLP contract research lab.
Manager - Chemical Sciencesat
Dr. Alan Hendricker has 15 years of experience in extractables and leachables analysis and 25 years of experience with mass spectrometry. He received his undergraduate degree from Ohio University and Ph.D. from the Colorado School of Mines in 1999. He was a co-author on the PQRI Working Group on Leachables and Extractables recommendation “Safety Thresholds and Best Practices for Leachables and Extractables in Orally Inhaled and Nasal Drug Products (OINDPs).” He has been an active member of the PQRI Leachables and Extractables Parenteral Ophthalmic Drug Product (PODP) working group. He has written and presented extensively on extractables and leachables issues. Alan was a member of the Structural Chemistry Group at Magellan Laboratories through its acquisitions by Cardinal Health and subsequent purchase by the Blackstone Group as Catalent Pharma Solutions. Since January of 2014, Alan works at Becton Dickinson (BD) as part of the corporate preclinical development group on extractables and leachables studies for BD devices and products.
Trace Analysics and E&L Scientist, at
Bio coming soon
Center Devices and Radiological Health, Office of Science & Eng. Lab., US Food & Drug Administration
Candice Johnson, Ph.D.
Candice Johnson, Ph.D. is a Research Scientist at Instem. She is working alongside an international consortium to develop in silico protocols for the assessment of skin sensitization, respiratory sensitization, and skin irritation/corrosion.
One of the aims of her work is to present a harmonized strategy for integrating in silico assessments of biological pathways which are relevant to each of the aforementioned endpoints. She is particularly interested in approaches used to derive a confidence measure in integrated assessments.
Dr. Johnson’s experience includes developing dose-response models and computational methods for environmental mixture assessments.
Scientific and Educational Affairs Managerat
Thermo Fisher Scientific
Currently a Staff Scientist with AstraZeneca in the Research Triangle Park (RTP) working on extractables and leachables (E&L). I have been in the field since 2001. I began my E&L career extracting and analyzing flavor compounds from soy protein. In 2005 I began to work with pMDI container closure systems. Currently manage the E&L activities at RTP and support other R&D groups within AstraZeneca. A member of the Materials Working Group within ELSIE and Knowledge Base sub-team I have been supporting the development of an extractables knowledge base. A member of the IPAC-RS Materials working group and involved with defining medical grade plastics and bio-compatibility. I have a Ph.D. in Physics from the University of Wyoming.
As general manager, Paul is responsible for the Smithers Analytical Services lab located in Akron to support extractables and leachables studies for the medical device, pharmaceutical and food industries. The lab also provides chemistry support to Smithers existing analytical and physical testing laboratories.
Paul’s specialty areas of expertise include mass spectrometry with a significant background in small molecule structure elucidation. He also has extensive experience in extractables and leachables and other areas of packaging testing such as container closure integrity.
Paul brings over 35 years of experience in chemistry and leadership in the pharmaceutical industry. Most recently he was a Research Fellow and Manager of Trace Organic Analysis for Intertek Pharmaceutical Services. He has also worked at West Pharmaceutical Services, Drugscan, GlaxoSmithKline and Merck.
Paul holds a Bachelor of Science degree in Chemistry from Old Dominion University and a Master of Science Degree in Analytical Organic Chemistry from Villanova University. He also served his country in the United States Army.
Sr. Director Scientific Affairsat
West Pharmaceutical Sciences
Diane Paskiet has over twenty-five years of experience in the pharmaceutical industry. She is currently Director of Scientific Affairs at West Pharmaceutical Services where she is involved in science and regulatory programs associated with safety and compatibility of pharmaceutical packaging and delivery systems. Previous to this role she was in charge of site operations for West-Monarch Analytical Laboratories. She is Chair of Product Quality Research Institute (PQRI) Development Technical Committee (DTC) and the Extractables and Leachables Parenteral Drug Product Working Group. Diane is also on the faculty of the Parenteral Drug Association Training Institute and a Board Member of Xavier Health Innovation Training Center of Excellence (ITCE). She has author/co-author a number of papers and book chapters related to pharmaceutical packaging, delivery systems and combination products.
Technical Scientific Liaisonat
Gyorgy Vas has over 20 years of experience in scientific research, product development, and laboratory management. Much of that time has been spent in a cGMP environment, where he has provided his expertise to solve problems related to finished pharmaceutical products and medical devices.
In his current position, he advises on regulatory filing strategies for multiple clients, and his group provides solutions for mitigating deficiency letters. Gyorgy led the implementation of state-of-the-art solventless sample preparation techniques into the cGMP laboratory processes, and is one of the few in this field with expertise in method development and validation for ultratrace (parts-per-trillion) level impurities in finished pharmaceutical products and medical devices.